about 1 year ago
Clinical Monitoring Manager
My client is a leading pharmaceutical company headquartered in Switzerland with locations worldwide and US operations based in Southern, NJ. Their therapeutic focus is in CNS, orphan diseases, and cardiovascular, and they are specialized in the discovery of small molecules to transform the horizon of therapeutic options.
Currently seeking a Country Monitoring Manager to manage the daily functions of the in-house start up and clinical operations group.
- Daily management of in-house startup and clinical ops group
- Support the Clinical Operations Coordinator in submission planning of ECs/IBR submissions
- Conduct Site Quality Visits with clinical trial sites
- Support the review and approval of all types of visit reports (site selection visit, site initiation visit, routine monitoring visits, close-out visits)
- Minimum Bachelor’s degree or healthcare profession degree
- 8+ years’ experience monitoring and conducting clinical research
- Involvement in study start up processes, investigator contract management and experience in preparing documents for submission to Ethics Committees/ IRBs
- Experience working with eTMF and Clinical Trial Management Systems